Drugplain

Topco Fiber Therapy Sugar Free 3.4 g/5.79g

Psyllium Husk · POWDER · TOPCO ASSOCIATES LLC

No Recall History
Plain English

Psyllium husk is a fiber supplement that helps relieve constipation and promote regular bowel movements. It comes as a powder you mix with liquid and take by mouth.

Key Facts

Brand Name
Topco Fiber Therapy Sugar Free
Generic Name
Psyllium Husk
NDC Code (Product)
36800-558
Manufacturer
TOPCO ASSOCIATES LLC
Strength
3.4 g/5.79g
Dosage Form
POWDER
Route
ORAL
Marketing Status
Application #
M007
Marketing Start
04/18/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use244 reports
pain228 reports
exposure during pregnancy218 reports
hypertension212 reports
constipation210 reports
headache210 reports
intentional product misuse194 reports
hyperhidrosis177 reports
joint swelling177 reports
food allergy176 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses: for relief of occasional constipation (irregularity) generally produces bowel movement in 12-72 hours

Dosage & Administration

Directions: Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. Adults & children 12 years & older: 1 rounded TEASPOON in 8 oz. of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Children 6-11 yrs : ½ adult dose in 8 oz. of liquid, up to 3 times daily Children under 6 yrs: Consult a doctor Bulk-forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. New Users: Start with 1 serving per day; gradually increase to 3 doses per day as necessary. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.

Warnings

Warnings: Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Allergy alert: This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium. Ask a doctor before use if you have a sudden change in bowel habits persisting for 2 weeks abdominal pain, nausea or vomiting Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These may be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Frequently Asked Questions

What is Topco Fiber Therapy Sugar Free used for?

Psyllium husk is a fiber supplement that helps relieve constipation and promote regular bowel movements. It comes as a powder you mix with liquid and take by mouth.

Is Topco Fiber Therapy Sugar Free a controlled substance?

Topco Fiber Therapy Sugar Free is not classified as a controlled substance by the DEA.

What is the generic name for Topco Fiber Therapy Sugar Free?

The generic name for Topco Fiber Therapy Sugar Free is Psyllium Husk. There are 11 other brand versions of Psyllium Husk.

What is the NDC code for Topco Fiber Therapy Sugar Free 3.4 g/5.79g?

The NDC (National Drug Code) for Topco Fiber Therapy Sugar Free 3.4 g/5.79g is 36800-558, listed by TOPCO ASSOCIATES LLC.

Product NDC

36800-558

Package NDC

36800-558-80

Other Psyllium Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)